Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) (PreMas)

October 3, 2018 updated by: María José Álvarez Álvarez, Universidad de León

Assessment of the Efficacy of Massage and Kinesiotherapy Applied by the Parents on the Biological State, Neuromotor Activity and Other Associated Factors in Hospitalized Premature Birth (PreMas)

The purpose of this study was to analyze the efficacy of massage therapy and kinesiotherapy, applied by the parents of hospitalized preterm infants, in the improvement of the biological state, neuromotor activity and other associated factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Premature infants are prematurely deprived of the cutaneous stimulation provided during intrauterine development and of the continuous contact with their parents. It has and adverse effect on both psychological and biological development of the child.

Knowledge of these factors has led many neonatal units to begin to introduce therapeutic massage protocols to facilitating satisfactory neuromotor and anthropometric development of preterm infants.

In this study, premature newborns were assigned to one of two groups:

A: Control Group. B: Massage and kinesiotherapy Group, 15 minutes twice a day.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age between 26 to 37 gestational weeks.
  • Low birth weight, less than 2249 grams.
  • Weight of at least 1250 grams at time of entry into study.
  • Must be at least 48 hours of age.
  • Must have hemodynamic stability.
  • Absence of congenital and genetic anomalies.
  • Absence of alterations of the central nervous system.
  • Intact skin.
  • Stable parameters (according to the neonatologist´s criteria) to participate in the intervention.

Exclusion Criteria:

  • Family refusal to participate in the study.
  • High frequency mechanical ventilation.
  • Fraction of Inspired Oxygen (FiO2)>70%.
  • Inotropic support.
  • Septic shock.
  • Persistent tachycardia.
  • Persistent bradycardia.
  • Gastrointestinal disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Routine Care
Control Group receives routine care.
EXPERIMENTAL: Massage and kinesiotherapy
Intervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each.
Behavioral: Protocol of massage therapy and kinesiotherapy
Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.
Other Names:
  • Massage
  • Massage Therapy
  • Tactile Kinesthetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on weight
Time Frame: From baseline to hospital discharge, approximately 10 days
Effect of treatment on weight
From baseline to hospital discharge, approximately 10 days
Effect of lenght
Time Frame: From baseline to hospital discharge, approximately 10 days
Effect of treatment on lenght
From baseline to hospital discharge, approximately 10 days
Effect on head circumference
Time Frame: From baseline to hospital discharge, approimately 10 days
Effect of treatment on head circumference
From baseline to hospital discharge, approimately 10 days
Effect on neuromotor development
Time Frame: From baseline to up to 37 gestational weeks

Effect of treatment on neuromotor development. Neuromotor development were measured using the Spanish Premie-Neuro Scale, a scale for the neurological examination of premature babies, between 23 and 37 gestational weeks.

It consists of twenty-four items divided into three factors: Neurological, movement and responsiveness, each with eight items. Each of the items is assigned a score of 1, 3 or 5. The scores for items are added up to yield a total raw score, with the possible figures for this ranging from 24 to 120 (higher values represent a better neuromotor development).
From baseline to up to 37 gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily weight gain
Time Frame: From baseline to hospital discharge, approimately 10 days
Effect of treatment on daily weight gain during the hospitalization period
From baseline to hospital discharge, approimately 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de León

Investigators

  • Principal Investigator: Daniel Fernández-García, PhD, Proffesor. Nursing and Physical Therapy Department. University of León.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2012

Primary Completion (ACTUAL)

January 2, 2013

Study Completion (ACTUAL)

December 30, 2015

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (ACTUAL)

October 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI12/02763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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